BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEAR DRO

    MDR report key: 7776888 · Received August 13, 2018

    Report

    Report Number
    0001822565-2018-04311
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    July 18, 2018
    Report Date
    December 4, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    PK101622
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN-(B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    REPORTED STAINS WERE CONFIRMED BY VISUAL EXAMINATION. IT WAS DETERMINED THE STAIN WAS CAUSED BY THE WAY THE TEAR DROP GUIDE WIRES ARE FIXTURED DURING PASSIVATION. THE GUIDE WIRES ARE PLACED ON A RACK WITH TWO OR MORE CONTACT POINTS. THESE CONTACT POINTS CAUSE A SMALL PORTION OF THE GUIDE WIRE TO NOT RECEIVE A FULL PASSIVATION COATING, LEADING TO AN INCONSISTENT COATING APPEARING AS A "STAIN" OR MARK. THESE STAINS ARE NOT CORROSION, AND DO NOT IMPACT THE FIT, FORM, OR FUNCTION OF THE GUIDEWIRES; THEY ARE MERELY COSMETIC. THE PRODUCT IS CONFORMING PER ZIMMER BIOMET'S CRITERIA. NO PRODUCT PROBLEM HAS BEEN IDENTIFIED AND THE DEVICES CONFORM TO THEIR SPECIFICATIONS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A STAIN WAS FOUND ON THE PRODUCT DURING INCOMING INSPECTION. NO ADVERSE EVENTS WERE REPORTED, AS THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619770 TEAR DRO ROD, FIXATION HSB ZIMMER BIOMET, INC. N/A 64040396

    Patients

    Seq Age Sex Outcome Treatment
    1